Abstract
BACKGROUND: Hospitalized patients usually have significant comorbidities and receive multiple medications which leads to a high frequency of contraindications to standard treatment options for acute gout (NSAIDs, colchicine, steroids). Adrenocorticotropic hormone (ACTH) has long been used in acute gout, exhibiting significant clinical efficacy and an excellent safety profile. AIM: To assess 1) the clinical efficacy of ACTH in gout compared to betamethasone in hospitalized patients 2) the safety profile of ACTH vs betamethasone and 3) the effect of ACTH on immune responses and metabolic parameters. METHODS: This is a randomized, open label comparative study directly comparing ACTH vs betamethasone for acute gout. We plan to recruit 60 hospitalized patients who will be randomly assigned to either the ACTH or the betamethasone group on a 1:1 basis. Patients will be clinically assessed at baseline and at 24, 48, 72h and 5days time points. (Intensity of pain, physician and patient global assessment, tenderness, swelling and redness). Serum and plasma samples will be collected at baseline and at the 24, 48, 72h time points from all study subjects. We will assess the effect of ACTH vs betamethasone on several metabolic parameters concentrating on glucose homeostasis. RESULTS: The study is currently recruiting patients. CONCLUSIONS: If the efficacy and safety profile of ACTH is verified in this randomized controlled trial, the use of ACTH for the treatment of gout in the hospital setting will be strongly supported.